# K993189: Cardiopulmonary Bypass Pump Tubing - 1/4 Inch Tubing, Cardiopulmonary Bypass Pump Tubing - 3/8 Inch Tubing

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Corp.
- Decided: Mar 1, 2000 after 160 days
- Product code: DWE (Tubing, Pump, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4390
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K022857: Pump Tubing with X-Coating (2002), 0 descendants of its own

## Indications for use
The Cardiopulmonary Bypass Pump Tubing is intended to provide a conduit for extracorporeal blood flow through a roller pump during cardiopulmonary bypass procedures. The tubing is intended for use in procedures lasting up to 6-hours in duration.

Source page: https://510kreport.com/device/K993189
Methodology: https://510kreport.com/methodology